# K964003: Metagen All Poly Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Metagen, LLC
- Decided: Mar 21, 1997 after 165 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orthomet All-Poly Acetabular Cup (Orthomet): named in the summary without a submission number
- (no number) Chamley/Elite Plus All Poly Cups (DePuy): named in the summary without a submission number
- (no number) StelKast All Poly Cup (StelKast): named in the summary without a submission number

## Indications for use
The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

Source page: https://510kreport.com/device/K964003
Methodology: https://510kreport.com/methodology